CN110461246A - For the biopsy needle close to periphery Lung neoplasm - Google Patents

For the biopsy needle close to periphery Lung neoplasm Download PDF

Info

Publication number
CN110461246A
CN110461246A CN201880018183.6A CN201880018183A CN110461246A CN 110461246 A CN110461246 A CN 110461246A CN 201880018183 A CN201880018183 A CN 201880018183A CN 110461246 A CN110461246 A CN 110461246A
Authority
CN
China
Prior art keywords
wall thickness
distal
length
needle
slender body
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201880018183.6A
Other languages
Chinese (zh)
Other versions
CN110461246B (en
Inventor
道格拉斯·W·加里蒂
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Scimed Inc
Original Assignee
Boston Scientific Scimed Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Scimed Inc filed Critical Boston Scientific Scimed Inc
Priority to CN202310906952.9A priority Critical patent/CN116831640A/en
Publication of CN110461246A publication Critical patent/CN110461246A/en
Application granted granted Critical
Publication of CN110461246B publication Critical patent/CN110461246B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B2010/009—Various features of diagnostic instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A61B2010/045—Needles

Abstract

The invention discloses medical device and the methods for manufacturing and using medical device.Example medical device may include lung biopsy needle, with proximal end, distal end and the slender body that extends between the proximal and distal ends.Needle can be configured to close to patient lungs periphery, and elongated portion can have first part, second part and puncture tip.First part can have the first flexibility and second part can have the second more flexible flexibility more flexible than first.Second part can extend in the distal side of first part, and the second flexibility can be constant along the length of second part.The first part of needle can have the wall thickness different from needle second part wall thickness.

Description

For the biopsy needle close to periphery Lung neoplasm
Cross reference to related applications
The disclosure requires the power of the U.S. Provisional Patent Application Serial No.62/472,128 submitted on March 16th, 2017 Benefit and priority；The disclosure of which is incorporated by reference.
Technical field
The disclosure belongs to medical device, and for manufacture and/or using medical device method.More particularly, the disclosure Belong to biopsy needle.
Background technique
Broad category of medical device is had been developed that for medical application, for example, lung uses.It is some in these devices Delivery apparatus and/or system including conduit, bracket, diagnostic tool etc., and for delivering such device.These devices pass through The manufacture of any one of various difference manufacturing methods, and can be used according to any one of various methods.In known medical treatment dress It sets, in delivery system and method, respectively there are certain merits and demerits.The medical device and delivery apparatus and use alternative to offer In manufacture and use medical device and the alternative methods of delivery apparatus, there are constant demands.
Summary of the invention
Present disclose provides the design of medical device, material, manufacturing method and use alternative.In a first aspect, lung Portion's biopsy needle may include proximal end, distal end and the slender body extended between the proximal and distal ends, and wherein the slender body can have There are first part, second part and puncture tip, which there can be the first level of flexibility and the second part can have Second level of flexibility more more flexible than the first level of flexibility, the second part can have in the first end of second part and second The length extended between end, and the second level of flexibility of the second part can along the length of second part be it is constant, And the second part of the slender body can be at the distal side of the distal end of the first part of slender body.
Additionally or alternatively, in second aspect, the first level of flexibility can be between 3.0lbf/in and 4.0lbf/in and Two level of flexibility can be between 0.1lbf/in and 1.0lbf/in.
Additionally or alternatively, in the third aspect, slender body can have first part distal end and second part it is close The transition portion extended between end, and the transition portion can have and gradually transit to second from the first level of flexibility along its length The level of flexibility of level of flexibility.
Additionally or alternatively, in fourth aspect, slender body may include the pipe for proximally extending to the starting point of puncture tip Chamber, and the lumen can have constant diameter.
Additionally or alternatively, at the 5th aspect, the first part of slender body can have first external diameter, the first external diameter edge From the proximal end of first part extend to first part distal end length be it is constant；And the second part of slender body can With second external diameter, which is constant along the length for the distal end for extending to second part from the proximal end of second part 's；And the second external diameter is smaller than first external diameter.
Additionally or alternatively, at the 6th aspect, first part can have coaxial with the central longitudinal axis of second part Central longitudinal axis.
Additionally or alternatively, at the 7th aspect, first part can have the first wall thickness, and first wall thickness is along from first The first length that the first end divided extends to the second end of first part is constant；And second part can have second Wall thickness, second wall thickness is less than the first wall thickness and along the second end for extending to second part from the first end of second part The second length be it is constant.
Additionally or alternatively, in eighth aspect, slender body can have first part distal end and second part it is close The transition portion extended between end, and the transition portion can have and gradually transit to the second wall thickness from the first wall thickness along its length Wall thickness.
Additionally or alternatively, at the 9th aspect, the second part of slender body extends to second from the proximal end of second part The length of partial distal end can be between five inches and ten inches.
Additionally or alternatively, at the tenth aspect, slender body may include transition portion, which has at first The length extended between the proximal end of the distal end and second part divided, and the length of the transition portion can be in 0.1 inch and 1.0 English Between very little.
Additionally or alternatively, on the one hand the tenth, the method for manufacture lung biopsy needle may include that selection has the first wall thickness Elongated tubular, which extends the length of the second end from the first end of elongated tubular to elongated tubular；Adjust elongated tubular Distal part wall thickness to less than the first wall thickness the second wall thickness, the distal part of the elongated tubular has the first wall in elongated tubular The distal side of thick portions of proximal extends.
Additionally or alternatively, at the 12nd aspect, this method may also include the wall thickness of adjustment transition portion, so that the transition Partial wall thickness is gradually decrease to the second wall thickness from the first wall thickness in the length of transition portion.
Additionally or alternatively, at the 13rd aspect, the wall thickness for adjusting the distal part of elongated tubular may include from distal part Material is removed so that the first external diameter of the outer diameter of distal part proximally part is decreased to second external diameter.
Additionally or alternatively, in fourteenth aspect, removing material from distal part may include grinding distal part.
Additionally or alternatively, at the 15th aspect, distal part can have constant wall thickness.
Additionally or alternatively, at the 16th aspect, the lumen of elongated tubular can have constant diameter.
Additionally or alternatively, at the 17th aspect, the distal part of elongated tubular can be along distal part from distal part The length that first end extends to the second end of distal part has constant level of flexibility.
Additionally or alternatively, at the 18th aspect, the method for obtaining tissue sample from patient lungs may include identification Lead to the path in tissue sample site in air flue；Flexible needle is introduced in air flue along path, wherein the flexible needle may include First part with the first length, first length have the first wall thickness；Second part with the second length, second length Spend the second wall thickness having less than the first wall thickness；There is the puncture tip of proximal end with the far-end in second part；By flexible needle Passage path of navigating is guiding the puncture tip of flexible needle to tissue sample site；Tissue sample is obtained with from tissue sample site Product.
Additionally or alternatively, at the 19th aspect, this method, which may also include, is inserted into flexible needle in the lumen of conduit.
Additionally or alternatively, at the 20th aspect, flexible needle can have constant inner diameter.
The above-mentioned summary of some embodiments is not intended to describe open embodiment each of of the invention or each embodiment. Following the drawings and specific embodiments more particularly illustrate these embodiments.
Detailed description of the invention
The disclosure can be more fully understood by being considered in conjunction with the accompanying following specific embodiments, in which:
Fig. 1 is the plan view close to the example biopsy tool of periphery Lung neoplasm；
Fig. 2 is the perspective view of example biopsy needle；
Fig. 3 is the side view of the example biopsy needle in Fig. 2；
Fig. 4 is the end-view of the example biopsy needle in Fig. 2；
Fig. 5 is the cross-sectional view of line 5-5 interception of the example biopsy needle in Fig. 4 in Fig. 2；
Fig. 6 is the flow chart for manufacturing the instance method of biopsy needle；With
Fig. 7 is the flow chart using the instance method of biopsy needle.
Although the disclosure can make various remodeling and alternative form, its details shows via the example in figure and will be detailed Carefully describe.However, it should be understood that the present invention is not intended to limit the invention to described specific embodiment.On the contrary, this hair It is bright to cover all remodeling, equivalent and the alternative form fallen into disclosure spirit and scope.
Specific embodiment
For term defined below, these definition should be applicable in, unless claim or this specification otherly Side gives different definition.
Assume that all numerical value are modified by term " about " herein, regardless of whether being explicitly indicated.Term " about " is usually Refer to that those skilled in the art think the digital scope for being equal to described value (that is, function having the same or result).In many feelings Under condition, term " about " may include the number being rounded to closest to effective digital.
By endpoint state numberical range include in the range all numbers (for example, 1 to 5 include 1,1.5,2, 2.75,3,3.80,4 and 5).
As used in this specification and appended claims, singular " one " and "the" include plural, unless Context is expressly otherwise indicated.As used in this specification and appended claims, term "or" includes usually using it The meaning of "and/or", unless context is expressly otherwise indicated.
It should be noted that it is described to refer to that " embodiment ", " some embodiments ", " other embodiments " etc. refer in specification Embodiment may include one or more specific features, structure and/or characteristic.However, such statement not necessarily shows all realities Applying example all includes specific feature, structure and/or the characteristic.In addition, regardless of whether being expressly recited, when combination one embodiment is retouched When stating special characteristic, structure and/or characteristic, it should be appreciated that this category feature, structure and/or characteristic can also be used for other embodiments, remove It non-clearly indicates opposite.
Following specific embodiments should refer to attached drawing reading, wherein the similar structures number in different attached drawings is identical.Attached drawing (it is not necessarily drawn to scale) shows exemplary embodiments and is not intended to be limited to the scope of the present disclosure.
The sprawling of global lung cancer combine the use of lung neoplasm screening can lead to chest computed tomography (CT) scanning or its It scans visible suspicious isolatism pulmonary nodule (SPN) quantity and increases.Suspicious SPN (it is typically found in lung periphery) It is likely difficult to be approached and diagnosed using mainly for current bronchoscope technology designed by central airway.Periphery lung knot Section or SPN may be the circular mass of up to 3 centimetres (cm) of measurement, can be benign or malignant.When identifying SPN, Biopsy may be needed to be diagnosed.In general, fine needle aspiration (FNA) can be used to patient throat or mouth through bronchus Mode close to the SPN identified and obtains biopsy from it in such a way that the thoracic cavity by patient is through thoracic cavity.In general, Through bronchus mode compared to through thoracic cavity mode can be advantageous, because can be realized close to SPN by the existing air flue of lung, and Without perforating to bodily tissue.However, passing through the air flue of lung because SPN is usually located in the deep periphery of lung It may be difficult or impossible for reaching SPN, it may be necessary to using by piercing through approaching through thoracic cavity mode for chest SPN.It, may be than being needed more through bronchus mode due to can be considered more more invasive than through bronchus mode through thoracic cavity mode Recovery time, it is desirable to provide a kind of to be configured to navigation and pass through the zigzag path in the deeps of pulmonary airways or distal part periphery Device.Such device allows doctor via the SPN through bronchus mode from positioned at the deep or distal part periphery of patient lungs Biopsy samples are obtained, which is previously passed non-accessible through bronchus mode.Although the disclosure relative to pulmonary nodule into Row description, it is contemplated that, method described herein and device can be applied to the other parts of anatomical structure, such as, but not limited to intestines Stomach, the urinary tract, gynaecology etc..
Fig. 1 shows the example biopsy syste 10 for advancing through trachea T and bronchial tree BT to lung L inner periphery tubercle 12 Plan view.In some cases, tubercle or lesion 12 can be located in the deep neighboring area of lung, due to lung's neighboring area gas The zigzag path in road is likely difficult to approach.
Although Fig. 1 depicts the biopsy syste 10 for reaching periphery tubercle 12, due to the complications of air flue at lung's depth periphery Property, the typical biopsy syste being used together in a manner of through bronchus with bronchoscope can not be close in lung's depth peripheries SPN.Although the needle of various specifications can be used in biopsy syste, including but not limited in 17 (17) specifications to 27 (27) Needle between specification, it was found that for attempting close to for the SPN in lung periphery, 25 (25) number gage needle may be Preferred size.Since 25 (25) number gage needle can have about 0.0120 inch of internal diameter and about 0.0203 inch outer Diameter, 25 (25) number gage needle can provide the preferred balance needed for crossing pulmonary airways between rigidity and flexibility, simultaneously Offer help to obtain the internal diameter of sufficient sample (once needle reaches SPN).Even so, it was found that 25 (25) number It the distal end of gage needle may be too hard and the air flue that cannot navigate through lung's depth peripheral portion.In addition, although 27 (27) number Gage needle can have more flexible distal end than 25 (25) number gage needle, but 27 (27) number gage needle may not have cross Nearside needed for wearing the air flue on lung's depth periphery is rigid and/or may not have the internal diameter of sufficient size (for example, internal diameter may be too It is small) reliably to obtain sample from SPN (for example, obtaining enough samples reliably from SPN to execute required survey to sample Examination), if reaching SPN.Disclosed needle by provide have be suitable for make needle traverse through lung's depth periphery nearside rigidity, It is flexible by the distal side on lung's depth periphery suitable for navigating, and for reliably obtaining sufficient sample from SPN once needle is positioned at SPN The suitable inner diameter of product (for example, obtaining enough samples reliably from SPN to execute required test to sample) is (for example, internal diameter is sufficient Needle enough greatly) solves this demand.
Fig. 2 depicts the perspective view of needle 20, and needle 20 is configured in holding axial strength to allow needle 20 to be inserted into target position While setting, the zigzag path of air flue in patient lungs' depth periphery is crossed.Needle 20 can have proximal end 22 and distal end 24, and have The slender body 26 extended between proximal end 22 and distal end 24.In order to be conducive to navigate to the periphery of patient lungs, needle 20 or needle 20 Slender body 26 can have one or more different flexibilities along its length.
Slender body 26 can have one or more parts.In the case where slender body can have more than one part, Slender body 26 can have at least first part 28 and second part 30.In addition, although not necessarily, slender body can have There are transition portion 32 and/or tip portion 34 (for example, penetrating tip, puncture tip, angled tip or other tips).
Fig. 3 is the side view of needle 20.As shown in figure 3, the second part 30 of slender body 26 can be the of slender body 26 The distal side of a part 28 extends, and in some cases, second part 30 (for example, distal part) can be fully in first The distal side of part 28 (for example, portions of proximal), but this is not all necessary in all cases.In an example, elongated The first part 28 of body 26 can extend to the proximal end of second part 30 from the proximal end of needle 20 22.When slender body 26 includes transition part When dividing 32, as the first part 28 of the needle 20 in Fig. 3, slender body 26 can extend to transition portion 32 from the proximal end of needle 20 22 Proximal end, and transition portion 32 can extend to the proximal end of second part 30 from the distal end of first part 28.Second part 30 can be from The distal end of transition portion 32 is distally extending.When slender body 26 includes tip portion 34, second part 30 can be from transition part The distal end divided extends to the proximal end of tip portion 34, and tip portion 34 can extend to needle 20 from the distal end of second part 30 Distally 24.
Each part of slender body 26 can have the length identical or different with slender body another part.According to needle 20 Application, slender body 26 prolongs between the proximal end of needle 20 22 (for example, first end) and the distal end 24 (for example, second end) of needle 20 The length stretched can be any length.For example, the length of slender body 26 can about 40 (40) inches to 100 (100) inches it Between, 50 (50) inches between 90 (90) inches, 60 (60) inches between 80 (80) inches, 65 (65) English It is very little between 70 (70) inches, and/or less than 40 (40) inches or be greater than the different length of 100 (100) inches.According to The application of needle 20, slender body 26 first part 28 proximally and distally between the length of first part 28 that extends can be to appoint What length.For example, the length of the first part 28 of slender body 26 can about 30 (30) inches between 90 (90) inches, 40 (40) inches between 80 (80) inches, 50 (50) inches between 70 (70) inches, 55 (55) inches To between 60 (60) inches, and/or less than 30 (30) inches or it is greater than the different length of 90 (90) inches.According to needle 20 Application, slender body second part 30 proximally and distally between the length of second part 30 that extends can be any length Degree.For example, the length of the second part 30 of slender body 26 can about two (2) inches between 20 (20) inches, four (4) English It is very little between 16 (16) inches, six (6) inches between 12 (12) inches, seven (7) inches between ten (10) inches, And/or less than two (2) inches or greater than the different length of 20 (20) inches.Although the length of transition portion 32 and tip portion 34 Degree is alterable, and transition portion 32 has about 0.1 inch to the length between two (2) inches, and tip portion 34 can have and be less than About one inch of length, and it is usually less than half inch of length in some cases.
In some cases, as disclosed herein, needle 20 can be configured to be advanced through in the deep or remote periphery of patient lungs Air flue is to reach the tubercle in lung or in lung.In this case, the total length of needle 20 can be in 50 (50) inches to eight Between ten (80) inches (for example, be or about 66 (66) inches or any other length), the first part 28 of needle 20 Length can in 50 (50) inches to (for example, be or about 56 inches or any other length) between 60 (60) inches, The length of two parts 30 can be between eight (8) inches and 12 (12) inches (for example, being or about 9.5 inches or any other Length), transition portion 32 can be between about 0.4 inch to 0.6 inch (for example, being or about 0.5 inch or any other length Degree), and the length of tip portion 34 is smaller than about 0.5 inch.
Although Fig. 3 depicts one that needle 20 includes first part 28, second part 30, transition portion 32 and tip portion 34 A exemplary configuration, but one or more of these parts can be removed from needle 20 and/or one or more parts may be added to that Needle 20.For example, in some cases, needle 20 may not include transition portion 32.Substitution or alternatively, needle 20 may include one or more A additional elongated portion (for example, being similar to one or both in first part 28 and second part 30) and/or one or Multiple additional transition portions.In the example that slender body includes one or more additional elongated portions, first Be divided to 28 and second part 30 can be two farthest sides elongated portion and/or second part 30 can be farthest side elongated portion. In some cases, additional elongated portion and/or transition portion can be conducive to add slender body 26 with different from elongated One or more parts of the flexibility (for example, level of flexibility) of 26 another part of ontology, wherein additional part can be used for increasing Or reduce flexibility/stiffness in 20 regional area of needle with facilitate access to the specific anatomical structure of patient and/or be conducive to it is auxiliary Medical device (for example, mirror or other medical devices) is helped to be used together.
As shown in figure 3, the first part 28 of slender body 26 can have second of first external diameter OD1 and slender body 26 Divide 30 there can be second external diameter OD2.Second external diameter OD2 is smaller than first external diameter OD1.In an example, second external diameter OD2 phase Than in first external diameter OD1 can between small about 0.001 inch to 0.007 inch, between about 0.002 inch to 0.006 inch, about Between 0.003 inch to 0.005 inch, about 0.004 inch or greater or lesser amount.In addition, in some cases, elongated The first external diameter OD1 of the first part 28 of body 26 can be along the length for the distal end for extending to first part 28 from the proximal end of first part 28 Degree is constant, but it's not necessary.Similarly, in some cases, outside the second of the second part 30 of slender body 26 Diameter OD2 can be constant along the length for the distal end for extending to second part 30 from the proximal end of second part 30, but this is not required 's.The opposite outside diameter of first part 28 and second part 30 can be conducive to provide to second part 30 soft different from first part 28 The flexibility of property.
Transition portion 32 (when being included in needle 20), which can have from the about first external diameter OD1 of first part 28, is tapered to The outer diameter of the about second external diameter OD2 of two parts 30.In some cases, the outer diameter of transition portion 32 it is tapered have it is constant tiltedly Rate.Alternatively, the slope that the outer diameter of transition portion 32 can have two or more different, transition portion 32 can have with stepping The outer diameter of outer diameter and/or transition portion 32 that mode is decreased to second external diameter OD2 from first external diameter OD1 can be with any other side Formula transits to second external diameter OD2 from first external diameter OD1.
Fig. 4 is the distal end view of needle 20 shown in Fig. 2 and Fig. 3.Needle 20 depicts the slender body 26 of needle 20, wherein transition part 32 are divided to extend to second part 30 from first part 28, second part 30 extends to tip portion 34, and tip portion 34 can be thin The farthest side section of long ontology 26.In addition, slender body 26 can limit lumen 36, has and limited by the internal diameter of slender body 26 Fixed diameter.
Fig. 5 is the cross-sectional view of line 5-5 interception of the needle 20 in Fig. 4.The first part 28 of slender body 26 can have first The second part 30 of internal diameter ID1 and slender body 26 can have the second internal diameter ID2.Second internal diameter ID2 can be equal to the first internal diameter ID1.In addition, in some cases, the first internal diameter ID1 of the first part 28 of slender body 26 can be along from the close of first part 28 The length that end extends to the distal end of first part 28 is constant, but it's not necessary.Similarly, in some cases, carefully Second internal diameter ID2 of the second part 30 of long ontology 26 can be along the distal end for extending to second part 30 from the proximal end of second part 30 Length be it is constant, but it's not necessary.When it is present, transition portion 32 can have edge to prolong from the proximal end of transition portion 32 The length for extending to the distal end of transition portion 32 is constant internal diameter.In some cases, first part 28, second part 30 and mistake The internal diameter that part 32 is crossed together with any other part extended between the proximal end of needle 20 22 and the proximal end of tip portion 34 can be The internal diameter that identical internal diameter makes slender body 26 that can have the proximal end for extending to tip portion 34 from the proximal end of needle 22 constant.So And, it is contemplated that, one or more parts of slender body 26 can have the internal diameter changed along part, and/or be different from thin The internal diameter of one or more of the other part of long ontology 26.
Fig. 5 shows the lumen 36 for extending to the distal end of second part 30 from the proximal end of needle 20 22 and leaving tip portion 34. Lumen 36 can have constant diameter along the length of needle, as limited by the internal diameter of slender body 26.In some cases, lumen 36 There can be the center longitudinal axis of the second longitudinal direction axis LA2 of the first longitudinal direction axis LA1 and second part 30 along first part 28 Line.In an example, first longitudinal direction axis LA1 can be coaxial with second longitudinal direction axis LA2, but it's not necessary.
The wall thickness of slender body 26 can be determined by subtracting the internal diameter of slender body 26 from the outer diameter of slender body 26.In Under some cases, when at least first part 28 and second part 30 of slender body 26 or slender body 26 are formed from the same material When, the wall thickness of slender body 26 can determine the flexibility of slender body 26 and/or thin together with the material property of the material of slender body The each part of long ontology 26 is (for example, the first part 28 of slender body 26, second part 30, transition portion 32, tip portion 34 And/or other parts) flexibility.
As shown in figure 5, the first part 28 of slender body 26 there can be the first wall thickness WT1, it is equal to first external diameter OD1 and subtracts Remove the first internal diameter ID1.The second part 30 of slender body 26 can have the second wall thickness WT2, be equal to second external diameter OD2 and subtract the Two internal diameter ID2.When slender body 26 includes transition portion 32, transition portion 32 can have to be similar to the outer of transition portion 32 How diameter from first external diameter OD1 transits to the wall that the mode of second external diameter OD2 transits to from the first wall thickness WT1 the second wall thickness WT2 It is thick.Additional elongated portion (when being included in slender body 26) can have and the first wall thickness WT1 and/or the second wall thickness WT2 Similar or different wall thickness, but it's not necessary.
In the example of fig. 5, the first part 28 of slender body 26 can have constant wall thickness WT1, to assign first Divide 28 constant flexibilities.However, according to desired nearside rigidity or flexibility, the first part 28 of slender body 26 can have along its length Spend the wall thickness of variation, and the flexibility therefore varied along its length.In the example of fig. 5, the second part 30 of slender body 26 can With constant wall thickness WT2, to assign second part constant flexibility.However, according to desired distal side rigidity or flexibility, elongated The second part 30 of body 26 can have the wall thickness varied along its length, and the flexibility therefore varied along its length.
In the example that needle 20 is configured to the SPN reached in lung's depth periphery and crosses pulmonary airways to reach SPN, Slender body can have the first wall thickness WT1 between about 0.0069 inch to 0.0091 inch (for example, 25 (25) number specification The wall thickness of needle) second part 30 between about 0.0029 inch to 0.0051 inch of first part 28, the second wall thickness WT2, And the constant inner diameter (for example, internal diameter of 25 (25) number gage needle) between about 0.0119 inch to 0.0121 inch.This Nearside rigidity or flexible needed for the needle 20 of class configuration can provide the air flue for making needle 20 cross lung's depth periphery, and cross lung's depth The rigidity or flexible of distal side needed for the zigzag path on periphery, at the same maintain internal diameter (for example, size of lumen 36) size be can Obtained by ground the SPN or tubercle that are located in lung's depth periphery sufficient sample (for example, the distal side rigidity of needle 20 or it is flexible reduce, But the same amount of sample for not sacrificing the size of lumen 36, therefore can obtaining from SPN and obtaining in other ways, but do not reduce needle The outer diameter or wall thickness of 20 second parts 30).
In addition, the first part 28 of the needle 20 for the dimensional configurations that there is previous paragraph to be discussed and second part 30 can be by lists Formed to part material monomer.When such needle 20 is constructed by cobalt chromium, the first part 28 of needle 20 can have that about 3.6lbf/in's is soft Property, and the second part 30 of needle 20 can have the flexibility of about 0.9lbf/in (for example, flexible soft compared to first part 28 Property increase 75%), wherein each part 28 of needle 20,30 flexibility can be by being commonly used in measurement flexible three in industry Point crooked test measures.When the first part 28 of needle 20 and second part 30 are monolithically formed (for example, by biocompatibility Stainless steel (such as cobalt chromium or other stainless steels) is monolithically formed) when, it is more than the exemplary needle for crossing pulmonary airways that needle 20, which can have, (for example, distal part be No. 25 specification cobalt chromium of standard, No. 25 300 series stainless steels of specification of standard, have helical cuts (for example, 120 inch pitch to 200 inch pitch) No. 25 specification cobalt chromium, No. 25 specification Nitinols needle) the advantages of, these advantage packets Include but be not limited to maintain nearside rigidity and the sample size that can obtain from needle, at the same increase distal side it is flexible and reduce material and manufacture at This.
Needle 20 disclosed herein can be made up of one or more manufacturing technologies.Method 100 shown in Fig. 6 provides system Make the instance method of needle 20.Method 100 may include selection elongated tubular 102.Selected elongated tubular can have the first wall thickness (for example, First wall thickness WT1 discussed above or the first different wall thickness) and/or specified specification (for example, 25 (25) number specification or its Its specification).In some cases, selected elongated tubular can have the first wall thickness between about 0.0069 inch to 0.0091 inch (for example, first external diameter is between about 0.0190 inch to 0.0210 inch, internal diameter about 0.0119 inch to 0.0121 inch it Between).
Selected elongated tubular can for tip portion (for example, puncture tip, penetrating tip, sharp or other points Point) preform needle.Alternatively, selected elongated tubular can be for original pipe and tip portion may be added to that the distal end of institute's needle selection.
Selected elongated tubular can be formed by any desired material.In an example, selected elongated tubular can integrally or At least partly formed by biocompatibility stainless steel (for example, cobalt chromium or other biocompatibility stainless steels).In some cases Under, elongated tubular can be monomer pipe or can be formed by two or more materials of integrally connected.
Once choosing elongated tubular, then the wall thickness of the distal part of elongated tubular can tune to the second wall thickness less than the first wall thickness 104 (for example, the second wall thickness WT2 discussed above or second different wall thickness).Second wall thickness of adjustment can be any size.In Under some cases, the wall thickness of adjustment can be between about 0.0029 inch to 0.0051 inch (for example, second external diameter is about 0.0150 Inch is between 0.0170 inch, and internal diameter is between about 0.0119 inch to 0.0121 inch).When this elongate tubular at and it is elongated When pipe is formed by cobalt chromium, the flexibility or rigidity of portions of proximal can be about 3.6lbf/in and the flexibility or rigidity of distal part can It is about 0.9lbf/in, as measured by 3 crooked tests of standard.
The part that the distal part of selected elongated tubular can extend for elongated tubular in the distal side of the portions of proximal of elongated tubular.One In a little situations, the distal part of selected elongated tubular can extend proximally from the distal end of elongated tubular or from the tip portion of elongated tubular Proximal end extends proximally the distance between about eight (8) inches to about 12 (12) inches.In an example, selected elongated tubular Distal part can be the second part 30 of slender body 26 discussed above.
In some cases, the second wall thickness of the distal part of elongated tubular can be constant along the length of distal part.This Constant wall thickness can lead to flexibility of the distal part with the consistent length along distal part to be conducive to cross lung's depth periphery Zigzag path.
In some cases, method 100 may include adjusting the transition portion of selected elongated tubular (for example, discussed above thin The transition portion 32 or different transition portions of long ontology 26) wall thickness.Compared with the such elongated tubular for not having transition portion (for example, with the elongated tubular of convex shoulder between portions of proximal with the first wall thickness and the distal part with the second wall thickness) When, the elongated tubular addition transition portion of Xiang Suoxuan can increase the stability of pipe and mitigate the distal portion with the second wall thickness of adjustment Divide a possibility that disconnecting from the portions of proximal with the first wall thickness.
When forming transition portion in selected elongated tubular, transition portion can have in the length of transition portion from the One wall thickness is gradually decrease to the wall thickness of the second wall thickness.In an example, transition portion can have at about 0.400 inch to about The wall thickness of the second wall thickness is gradually transitted in 0.600 inch of length from the first wall thickness.In some cases, the length of transition portion About 100 (100) times for spending the difference between the first wall thickness and the second wall thickness, but it's not necessary.
The wall thickness of selected elongated tubular can be adjusted in any way.In some cases, the wall thickness of selected elongated tubular can Material is removed by the outer diameter (for example, from distal part and/or transition portion) from elongated tubular to adjust.It is alternatively or additional Ground, adjustment elongated tubular distal part relative to the wall thickness of elongated tubular portions of proximal may include material is added to elongated tubular (for example, To portions of proximal and/or transition portion) and/or by typical tube formed technology (including but not limited to squeeze, stretch and/or its Its technology) manipulate in other ways elongated tube portion wall thickness relative size.
When material removes the wall thickness to adjust distal part from the outer diameter of elongated tubular, using any removal technology.In In one example, the distal part of selected elongated tubular can be ground to desired outer diameter to be formed to have and it is expected wall thickness flexible.Root Other removal technologies, including but not limited to milling technology, turning technology, technology of boring and grinding, lappingout technology, planning can be utilized according to needs Technology and/or other removal technologies.
The flexibility of farthest side elongated portion can be taken less than the flexibility compared with nearside elongated portion according to the needle that method 100 is formed Various forms.In an example, according to method 100 formed needle can have tip portion (for example, tip portion 34 or its Its tip portion), the distal part (for example, second part 30 or other distal parts) that is extended proximally from tip portion and The portions of proximal (for example, first part 28 or other portions of proximal) that the nearside of distal part extends, wherein distal part is soft Property be greater than the flexibility of portions of proximal, distal part and portions of proximal have the proximal end of proximally part to the distal end of distal part permanent Fixed internal diameter, and distal part and portions of proximal are monolithically formed.In some cases, the needle of formation is in portions of proximal and remote There can be transition portion (for example, transition portion 32 or other transition portions) between side section, wherein transition portion has from about It is gradually transition to the flexibility flexible of distal part for the flexibility of portions of proximal, has identical as distal part and portions of proximal Internal diameter, and monolithically formed with distal part and portions of proximal.However, it is contemplated that other constructions, including by two kinds or more Needle made of multiple material construction and/or there is the needles of one or more parts in the nearside of portions of proximal.
Fig. 7, which is shown, obtains group from patient lungs using flexible needle (for example, needle 20 or other needles) in the course of surgery The method 200 of tissue samples.Method 200 may include that the path 202 for leading to tissue sample site is identified in air flue.In air flue Path can identify in any way.In an example, path can be in SPN for identification or other tubercles (for example, target position Point) it identifies in identical or different CT scan.Alternatively, one or more other scannings or imaging technique can be used to be identified by lung Portion's air flue is to the path of target site.Once identifying outbound path, flexible needle (for example, needle 20 or other needles with constant inner diameter) It can be introduced to 204 in air flue along the path identified.It may include that flexible needle is inserted into conduit that flexible needle, which is introduced to path, Lumen and/or bronchoscope lumen in.Flexible needle may include having the first wall thickness (for example, the first wall thickness discussed above WT1 or different wall thickness) length first part (for example, first part 28 or other first parts), have less than the first wall The second part of the length of thick the second wall thickness (for example, the second wall thickness WT2 discussed above or different wall thickness) is (for example, second Part 30 or other second parts), and second part far-end with the tip portion of proximal end (for example, have puncture tip Hold, penetrate the tip portion 34 or other tip portions at tip, sharp tip).
After flexible needle is inserted into identified path, method 200 may include that flexible needle navigation is passed through identified road Diameter is to target sample site (for example, to SPN or other tubercles).Once reaching target sample site, this method may include from group Tissue samples site (for example, from SPN or other tubercles) obtains tissue sample 208.In some cases, sample can be by making flexibility The tip portion of needle engages SPN or tubercle or other tissues and obtains, when tip portion engages SPN or tubercle or other tissues When, extract syringe out, which is connected to generate vacuum by the lumen of flexible needle and sample is pumped to needle with flexible needle Lumen in.After obtaining a sample, sample and/or flexible needle can be extracted out from patient's body, and sample can be confirmed as deriving from SPN or tubercle.If sample is confirmed as the sample of non-SPN or tubercle, method 200 is repeated.
As discussed above for needle 20, flexible needle can have the constant inner diameter or diameter of its lumen, be configured to advantageous In the distal end for obtaining the size of enough samples from SPN or other tubercles, while there is flexibility to increase.In the flexible needle of such configuration In, the internal diameter or diameter dimension of flexible needle lumen allow vacuum power bigger in needle lumen (compared to needle distal wall thickness and The internal diameter of distal end reduces to increase the needle vacuum power obtained of distal flexible) more preferably to collect sample in response to extraction syringe Product.
Although as discussed above the specific material about needle 20, but needle 20 may include usually associated with medical device What material.For purposes of brevity, following the discussion refers to needle 20.However, this be not intended to limit apparatus described herein and Method, because the discussion can be applied to the other similar systems and/or component of system disclosed herein or device.
Needle 20 can by metal, metal alloy, polymer (some examples are disclosed below), metal-polymer composites, Ceramics, a combination thereof etc. or other suitable materials are made.Some examples of suitable polymer may include polytetrafluoroethylene (PTFE) (PTFE), Ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP) (FEP), polyformaldehyde (POM, for example, being available from DuPont's)、 Polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether ester (example Such as, it is available from DSM Engineering Plastics's), ether or ester group copolymer (for example, butylene/ Poly- (alkylene ether) phthalic acid ester and/or other polyester elastomers, are such as available from DuPont's), it is poly- Amide is (for example, be available from Bayer'sOr it is available from Elf Atochem's), bullet Property polyamide, block polyamide/ether, polyether block amide (PEBA, for example, can be with trade nameObtain), ethylene second Vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high density polyethylene (HDPE), Marlex low density polyethylene (LDPE), line Property low density polyethylene (LDPE) (for example,), polyester, polybutylene terephthalate (PBT) (PBT), poly terephthalic acid Glycol ester (PET), polyethylene naphthalate (PEN), polyether-ether-ketone (PEEK), gathers polybutylene terephthalate (PBT) Acid imide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (example Such as,), polysulfones, nylon, Nylon-12 (such as, be available from EMS AmericanGrilon's), it is perfluor (propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefin, polystyrene, epoxy resin, poly- Vinylidene chloride (PVdC), poly- (styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), poly- carbonic acid Ester, ionomer, biocompatible polymer, other suitable materials, or mixtures thereof, combination, copolymer, polymer/metal is multiple Close object, etc..In some embodiments, liquid crystal polymer (LCP) can be blended in polymer.For example, mixture can be containing up to About 6% LCP.
Some examples of suitable metal and metal alloy include stainless steel (such as 304V, 304L and 316LV stainless steel), soft Steel, Nitinol (such as linear elasticity and/or superelastic Nitinol), other nickel alloys (such as NI-CR-MO alloys (for example, UNS: N06625, such as625；UNS:N06022, such asUNS:N10276, Such asIt is otherAlloy, etc.)), monel (for example, UNS: N04400, such as400、400、400, etc.), nickel cobalt chrome molybdenum Alloy (for example, UNS:R30035, such asDeng), nickel-molybdenum alloy (for example, UNS:N10665, such asALLOY), other nichromes, other nickel-molybdenum alloys, other nickel cobalt (alloy)s, other ferronickels close Golden, other monels, other nickel tungstens or tungsten alloy etc., cochrome, vitallium are (for example, UNS:R30003, all Such asDeng), rich platinum stainless steel, titanium, a combination thereof etc. or any other suitable material.
As mentioned in this article, in the family of commercially available Ni-Ti or nitinol, have referred to as " linear elasticity " or " non- The classification of super-elasticity " can be in although it can be similar to common shape memory and super-elasticity type in terms of chemical property Reveal unique and beneficial mechanical performance.The difference of linear elasticity and/or non-superelastic Nitinol and superelastic Nitinol can be, Linear elasticity and/or non-superelastic Nitinol do not have " the super-elasticity level ground " of essence in stress/strain curves (" superelastic plateau ") or " marked region " (" flag region "), and superelastic Nitinol then has.Phase Instead, in linear elasticity and/or non-superelastic Nitinol, as recoverable strain increases, stress is with substantial linear, or slightly line Property, but relationship that need not be fairly linear persistently increases until plastic deformation starts or at least than shown in superelastic Nitinol Super-elasticity level ground and/or the more linear relationship of marked region.In this way, for purposes of this disclosure, linear elasticity and/or non-super-elasticity Nitinol is alternatively referred to as " substantially " linear elasticity and/or non-superelastic Nitinol.
In some instances, the difference of linear elasticity and/or non-superelastic Nitinol and superelastic Nitinol can also be, line Elastic and/or non-superelastic Nitinol can bear up to big while (for example, before plastic deformation) keeping substantially resilient The strain of about 2-5%, and superelastic Nitinol can bear up to about 8% strain before plastic deformation.Both materials (it can also be differentiated according to its component), other line bullets can be differentiated with other linear elastic materials of such as stainless steel Property material can only bear about 0.2 to 0.44% strain before plastic deformation.
In some embodiments, linear elasticity and/or non-superelastic nickel-titanium alloy are that do not have in very big temperature range By differential scanning calorimeter (DSC) and dynamic metal heat analysis (DMTA) can analyze and detect to obtain any martensitic phase Change/austenite phase transformation alloy.For example, in some embodiments, arriving about 120 DEG C of model at about -60 degrees Celsius (DEG C) Linear elasticity and/or non-superlastic are not measured by differential scanning calorimeter (DSC) and dynamic metal heat analysis (DMTA) analysis in enclosing Martensitic traoformation/austenite phase transformation of property Ni-Ti alloy.Therefore, within the scope of this very broad temperature, this material Mechanical bend performance will not be usually affected by temperature.In some embodiments, linear elasticity and/or non-superelastic nickel-titanium Alloy mechanical bend performance at ambient or room temperature and mechanical performance under body temperature are essentially identical, for example, not showing Show super-elasticity level ground and/or marked region.In other words, within the scope of broad temperature, linear elasticity and/or non-superelastic nickel-titanium Alloy keeps its linear elasticity and/or non-super elastic characteristics and/or performance.
In some embodiments, linear elasticity and/or non-superelastic nickel-titanium alloy can contain about 50 to about 60 weight half point ratios Nickel, rest part then be substantially titanium.In some embodiments, composition contains the nickel of about 54 to about 57 weight percent. One example of suitable Ni-Ti alloy is commercially available from the Furukawa Techno Material Co. of Kanagawa, Japan FHP-NT alloy.Some examples of Nitinol in the U.S. Patent number 5,238,004 and 6 being herein incorporated by reference, It is disclosed in 508,803.Other suitable materials may include ULTANIUMTM(can be bought from Neo-Metrics) and GUM METALTM (can be bought from Toyota).In some other embodiments, superelastic alloy, such as superelastic Nitinol can be used to realize Required characteristic.
In at least some embodiments, some or all of needle 20 can be made from it doped with radiopaque material, or It in other ways include radiopaque material.Radiopaque material is understood as saturating in fluorescence during medical operating The material of relatively bright image is generated on screen curtain or another imaging technique.The relatively bright image facilitates making for needle 20 User determines its position.Some examples of radiopaque material may include but be not limited to gold, platinum, palladium, tantalum, tungsten alloy, be loaded with The polymer material etc. of radiopaque filler.In addition, other radiopaque label bands and/or coil also may be incorporated into setting for needle 20 To realize identical result in meter.
In some embodiments, 20 a degree of magnetic resonance imaging (MRI) of needle compatibility is assigned.For example, needle 20 or Its part or component can be by not making image fault substantially and generating the material system in a large amount of pseudomorphisms (for example, gap in image) At.For example, certain ferromagnetic materials may be inappropriate, because they may generate artifact on MRI image.Needle 20 or its Part may also comprise and/or be made of the material that MRI machine can be imaged.The some materials for showing these characteristics include for example Tungsten, vitallium are (for example, UNS:R30003, such asDeng), nickel cobalt chrome molybdenum (for example, UNS:R30035, such asDeng), Nitinol etc. and other.
It should be understood that the disclosure is only illustrative in many aspects.Without departing from disclosure range, in details Aspect can make variation, especially in terms of shape, size and procedure.In appropriate degree, this may include by a reality Any of feature of example embodiment is in other embodiments.Certainly, the scope of the present invention is to state appended claims Language limit.

Claims (15)

1. a kind of lung biopsy needle, comprising:
Proximal end；
Distally；With
The slender body extended between the proximal end and the distal end；
Wherein:
The slender body has first part, second part and puncture tip；
The first part is with the first level of flexibility and the second part is with more more flexible than first level of flexibility Second level of flexibility；
The second part has the length extended between the first end and the second end of the second part, and described Second level of flexibility of second part is constant along the length of the second part；And
The second part of the slender body is in the distal side of the distal end of the first part of the slender body.
2. lung biopsy needle according to claim 1, wherein first level of flexibility is in 3.0lbf/in and 4.0lbf/ Between in and second level of flexibility is between 0.1lbf/in and 1.0lbf/in.
3. lung biopsy needle according to claim 1, wherein the slender body has in the distal end of the first part The transition portion extended between the proximal end of the second part, and the transition portion has along its length from described first Level of flexibility gradually transits to the level of flexibility of second level of flexibility.
4. lung biopsy needle according to claim 1, wherein the slender body include extended to from the proximal end it is described The lumen of the starting point of puncture tip, and the lumen has constant diameter.
5. lung biopsy needle according to claim 1, wherein the first part of the slender body has outside first Diameter, length of the first external diameter along the distal end for extending to the first part from the proximal end of the first part is constant； And the second part of the slender body has a second external diameter, and the second external diameter is along from the proximal end of the second part It is constant for extending to the length of the distal end of the second part；And the second external diameter is less than the first external diameter.
6. lung biopsy needle according to claim 5, wherein the first part has the center with the second part The coaxial central longitudinal axis of longitudinal axis.
7. lung biopsy needle according to claim 1, wherein the first part has the first wall thickness, first wall thickness The first length along the second end for extending to the first part from the first end of the first part is constant；And The second part has the second wall thickness, and second wall thickness is less than first wall thickness and along from the first of the second part The second length that end extends to the second end of the second part is constant.
8. lung biopsy needle according to claim 7, wherein the slender body has in the distal end of the first part The transition portion extended between the proximal end of the second part, and the transition portion has along its length from described first Wall thickness gradually transits to the wall thickness of second wall thickness.
9. lung biopsy needle according to claim 1, wherein the second part of the slender body is from described second Partial proximal end extends to the length of the distal end of the second part between five inches and ten inches.
10. lung biopsy needle according to claim 1, wherein the slender body includes transition portion, the transition part Divide with the length extended between the distal end of the first part and the proximal end of the second part, and the length exists Between 0.1 inch and 1.0 inches.
11. a kind of method for manufacturing lung biopsy needle, which comprises
Select the elongated tubular with the first wall thickness, first wall thickness extends from the first end of the elongated tubular to described elongated The length of the second end of pipe；
Adjust the wall thickness of the distal part of the elongated tubular to less than the second wall thickness of first wall thickness, the institute of the elongated tubular Stating distal part in the elongated tubular there is the distal side of the portions of proximal of first wall thickness to extend.
12. according to the method for claim 11, further includes:
The wall thickness for adjusting transition portion, so that the wall thickness of the transition portion is in the length of the transition portion from described first Wall thickness is gradually decrease to second wall thickness.
13. according to the method for claim 11, wherein the wall thickness for adjusting the distal part of the elongated tubular includes from described Distal part removes material so that the outer diameter of the distal part is decreased to second external diameter from the first external diameter of the portions of proximal.
14. according to the method for claim 13, wherein removing material from the distal part includes grinding the distal portion Point.
15. according to the method for claim 11, wherein the distal part has constant wall thickness.
CN201880018183.6A 2017-03-16 2018-03-09 Biopsy needle for accessing peripheral lung nodules Active CN110461246B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202310906952.9A CN116831640A (en) 2017-03-16 2018-03-09 Biopsy needle for accessing peripheral lung nodules

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762472128P 2017-03-16 2017-03-16
US62/472,128 2017-03-16
PCT/US2018/021792 WO2018169791A1 (en) 2017-03-16 2018-03-09 Biopsy needle for accessing peripheral lung nodules

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN202310906952.9A Division CN116831640A (en) 2017-03-16 2018-03-09 Biopsy needle for accessing peripheral lung nodules

Publications (2)

Publication Number Publication Date
CN110461246A true CN110461246A (en) 2019-11-15
CN110461246B CN110461246B (en) 2023-08-08

Family

ID=61764159

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201880018183.6A Active CN110461246B (en) 2017-03-16 2018-03-09 Biopsy needle for accessing peripheral lung nodules
CN202310906952.9A Pending CN116831640A (en) 2017-03-16 2018-03-09 Biopsy needle for accessing peripheral lung nodules

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN202310906952.9A Pending CN116831640A (en) 2017-03-16 2018-03-09 Biopsy needle for accessing peripheral lung nodules

Country Status (8)

Country Link
US (2) US10898171B2 (en)
EP (1) EP3595537A1 (en)
JP (2) JP7062661B2 (en)
KR (2) KR102569983B1 (en)
CN (2) CN110461246B (en)
AU (1) AU2018234510B2 (en)
CA (2) CA3046563C (en)
WO (1) WO2018169791A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112807522A (en) * 2021-03-10 2021-05-18 山东孟友玻璃科技有限公司 Flexible needle tube, preparation method thereof and flexible instillation needle

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109712131B (en) * 2018-12-27 2021-04-16 上海联影智能医疗科技有限公司 Method and device for quantifying lung nodule characteristics, electronic equipment and storage medium
US11020099B1 (en) * 2020-07-01 2021-06-01 Verix Health, Inc. Lung access device
US11033298B1 (en) * 2020-07-01 2021-06-15 Verix Health, Inc. Lung access device

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5868684A (en) * 1993-12-22 1999-02-09 Radi Medical Systems Ab Device for hard tissue biopsy sampling
US6110128A (en) * 1998-12-11 2000-08-29 Andelin; John B. Bone marrow biopsy needle and method for using the same
US20030236506A1 (en) * 2002-06-20 2003-12-25 Eric Schofield Dual outside diameter cannula for insertion into bone
US20060189891A1 (en) * 2004-12-15 2006-08-24 Irving Waxman Flexible elongate surgical needle device having a tissue engaging section being of greater flexibility than an intermediate section, and methods of using the device
US20110196258A1 (en) * 2010-02-05 2011-08-11 Shawn Ryan Nesting endoscopic ultrasound guided biopsy device
US20130006144A1 (en) * 2011-06-28 2013-01-03 Michael Clancy Biopsy needle with flexible length
CN104602615A (en) * 2013-03-13 2015-05-06 斯波瑞申有限公司 Device for minimally invasive delivery of treatment substance
US20150265258A1 (en) * 2011-06-28 2015-09-24 Ciaran Toomey Flexible biopsy needle
US20160361088A1 (en) * 2015-06-12 2016-12-15 Covidien Lp Catheter with pre-formed geometry for body lumen access

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3955579A (en) * 1973-07-23 1976-05-11 Henry Bridgman Vacuum curet
US4976690A (en) * 1989-08-10 1990-12-11 Scimed Life Systems, Inc. Variable stiffness angioplasty catheter
US5238004A (en) 1990-04-10 1993-08-24 Boston Scientific Corporation High elongation linear elastic guidewire
US5533985A (en) * 1994-04-20 1996-07-09 Wang; James C. Tubing
US5964740A (en) 1996-07-09 1999-10-12 Asahi Kogaku Kogyo Kabushiki Kaisha Treatment accessory for an endoscope
US6086543A (en) 1998-06-24 2000-07-11 Rubicor Medical, Inc. Fine needle and core biopsy devices and methods
US6508803B1 (en) 1998-11-06 2003-01-21 Furukawa Techno Material Co., Ltd. Niti-type medical guide wire and method of producing the same
US6770070B1 (en) * 2000-03-17 2004-08-03 Rita Medical Systems, Inc. Lung treatment apparatus and method
EP1656963B1 (en) 2004-11-10 2007-11-21 Creganna Technologies Limited Stent delivery catheter assembly
US8251963B2 (en) 2005-12-08 2012-08-28 Boston Scientific Scimed, Inc. Flexible needle
WO2011123689A1 (en) * 2010-03-31 2011-10-06 Boston Scientific Scimed, Inc. Guidewire with a flexural rigidity profile
JP6290099B2 (en) * 2012-02-03 2018-03-07 インテュイティブ サージカル オペレーションズ， インコーポレイテッド Steerable flexible needle with implantable shape sensing function
US20130225996A1 (en) 2012-02-28 2013-08-29 Spiration, Inc. Lung biopsy needle
WO2014060116A1 (en) 2012-10-19 2014-04-24 Brunner Phillippe Medical device comprising a curved needle
WO2015073675A1 (en) 2013-11-15 2015-05-21 Boston Scientific Scimed, Inc. Needle biopsy systems
US10856855B2 (en) * 2013-12-13 2020-12-08 Intuitive Surgical Operations, Inc. Telescoping biopsy needle
WO2016105769A1 (en) 2014-12-23 2016-06-30 Boston Scientific Scimed, Inc. Marker for detection and confirmation of peripheral lung nodules
WO2016160712A1 (en) 2015-04-01 2016-10-06 Boston Scientific Scimed, Inc. Pulmonary biopsy devices
US20160361047A1 (en) 2015-06-11 2016-12-15 Boston Scientific Scimed, Inc. Flexible Biopsy Needle
CN115429337A (en) 2016-05-31 2022-12-06 直观外科手术操作公司 Compliant biopsy needle system

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5868684A (en) * 1993-12-22 1999-02-09 Radi Medical Systems Ab Device for hard tissue biopsy sampling
US6110128A (en) * 1998-12-11 2000-08-29 Andelin; John B. Bone marrow biopsy needle and method for using the same
US20030236506A1 (en) * 2002-06-20 2003-12-25 Eric Schofield Dual outside diameter cannula for insertion into bone
US20060189891A1 (en) * 2004-12-15 2006-08-24 Irving Waxman Flexible elongate surgical needle device having a tissue engaging section being of greater flexibility than an intermediate section, and methods of using the device
US20110196258A1 (en) * 2010-02-05 2011-08-11 Shawn Ryan Nesting endoscopic ultrasound guided biopsy device
US20130006144A1 (en) * 2011-06-28 2013-01-03 Michael Clancy Biopsy needle with flexible length
US20150265258A1 (en) * 2011-06-28 2015-09-24 Ciaran Toomey Flexible biopsy needle
CN104602615A (en) * 2013-03-13 2015-05-06 斯波瑞申有限公司 Device for minimally invasive delivery of treatment substance
US20160361088A1 (en) * 2015-06-12 2016-12-15 Covidien Lp Catheter with pre-formed geometry for body lumen access

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112807522A (en) * 2021-03-10 2021-05-18 山东孟友玻璃科技有限公司 Flexible needle tube, preparation method thereof and flexible instillation needle

Also Published As

Publication number Publication date
WO2018169791A1 (en) 2018-09-20
KR20210150610A (en) 2021-12-10
CA3194889A1 (en) 2018-09-20
US20180263607A1 (en) 2018-09-20
CN116831640A (en) 2023-10-03
US10898171B2 (en) 2021-01-26
JP2022095942A (en) 2022-06-28
KR20190123334A (en) 2019-10-31
KR102336928B1 (en) 2021-12-08
CA3046563A1 (en) 2018-09-20
JP7062661B2 (en) 2022-05-06
AU2018234510A1 (en) 2019-05-30
CA3046563C (en) 2024-02-13
CN110461246B (en) 2023-08-08
KR102569983B1 (en) 2023-08-22
US20210128124A1 (en) 2021-05-06
AU2018234510B2 (en) 2020-07-30
EP3595537A1 (en) 2020-01-22
JP2020513881A (en) 2020-05-21

Similar Documents

Publication Publication Date Title
CN110461246A (en) For the biopsy needle close to periphery Lung neoplasm
AU2017201668B2 (en) Medical devices for use along the biliary and/or pancreatic tract
US10932679B2 (en) Pressure sensing guidewires and methods of use
CN106455997A (en) Double micro-electrode catheter
JP6848058B2 (en) Medical device withdrawal system
US20160178519A1 (en) Marker For Detection And Confirmation Of Peripheral Lung Nodules
CN106170245A (en) Intracavity aperture sensor array device
WO2015080948A1 (en) Medical devices for accessing body lumens
US20180206870A1 (en) Rotatable medical device
CN117615720A (en) Left auricle closing device
CN110430912A (en) Haemostatic valve for guide sheath designs
CN116710006A (en) Balloon annuloplasty catheter with intravascular ultrasound
US11445893B2 (en) Medical device connection member
KR20210030436A (en) Scalable medical device used with needles
US9017246B2 (en) Biliary catheter systems including stabilizing members
WO2023154565A1 (en) Tissue sample device and methods
CN116635104A (en) Catheter capable of bidirectional steering
CN110536649A (en) Variable-length blood vessel plugging system

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant